Department of Justice Files Nationwide Lawsuit Against AmerisourceBergen Corp. and Subsidiaries for Controlled Substances Act Violations
NEWARK, N.J. – In a civil complaint filed today, the Department of Justice alleges that AmerisourceBergen Corp. and two of its subsidiaries, AmerisourceBergen Drug Corp. and Integrated Commercialization Solutions LLC (AmerisourceBergen), collectively one of the country’s largest wholesale pharmaceutical distributors and one of the largest companies in America by revenue, violated the law in connection with the distribution of controlled substances to pharmacies and other customers across the country, contributing to the prescription opioid epidemic.
The complaint alleges that this unlawful conduct resulted in at least hundreds of thousands of violations of the Controlled Substances Act (CSA). The Justice Department seeks civil penalties and injunctive relief.
“For years, AmerisourceBergen put its profits from opioid sales over the safety of Americans,” U.S. Attorney for the District of New Jersey Philip R. Sellinger said. “According to the complaint, this was part of a brazen, blatant, and systemic failure by one of the largest companies in America to comply with its obligations to report suspicious opioid orders, contributing to the epidemic of opioid abuse throughout this country.”
“The Department of Justice is committed to holding accountable those who fueled the opioid crisis by flouting the law,” Associate Attorney General Vanita Gupta said. “Companies distributing opioids are required to report suspicious orders to federal law enforcement. Our complaint alleges that AmerisourceBergen—which sold billions of units of prescription opioids over the past decade—repeatedly failed to comply with that requirement.”
“The mission of the DEA is to enforce the Controlled Substances Act, and as this complaint alleges, AmerisourceBergen violated the CSA hundreds of thousands of times,” Susan A. Gibson, Special Agent in Charge of the DEA’s New Jersey Division, said. “AmerisourceBergen was required by law to report suspicious orders to the DEA, and they failed in their obligation to do so. This failure contributed to the opioid epidemic that has plagued this country for years. This multi-year investigation and resulting lawsuit will hold AmerisourceBergen accountable for their actions.”
“AmerisourceBergen, one of the largest wholesale distributors of opioids in the world, had a legal obligation to report suspicious orders to the Drug Enforcement Administration, and our complaint alleges that the company’s repeated and systemic failure to fulfill this simple obligation helped ignite an opioid epidemic that has resulted in hundreds of thousands of deaths over the past decade,” DEA Administrator Anne Milgram said. “The men and women of the DEA will stop at nothing to hold accountable registrants that fail to uphold their responsibility of saving American lives by filing suspicious order reports.”
Pharmaceutical distributors that sell controlled substances, including AmerisourceBergen, have a longstanding legal obligation to monitor the orders that they receive from pharmacies and other customers and must inform the Drug Enforcement Administration (DEA) each and every time they receive a suspicious order.
The complaint filed in the U.S. District Court for the Eastern District of Pennsylvania alleges that over the course of nearly a decade, from 2014 through the present, AmerisourceBergen violated the CSA by failing to report at least hundreds of thousands of suspicious orders of controlled substances to the DEA as required by law. The alleged unlawful conduct includes filling and failing to report numerous orders from pharmacies that AmerisourceBergen knew were likely facilitating diversion of prescription opioids. Today’s filing is the result of a multi-year investigation by the DEA, the District of New Jersey, the Civil Division’s Consumer Protection Branch, several other U.S. Attorneys’ Offices.
The government’s complaint specifies several pharmacies for which AmerisourceBergen allegedly was aware of significant “red flags” suggesting the existence of diversion of prescription drugs to illicit markets. The complaint asserts that AmerisourceBergen nevertheless continued to distribute drugs to the pharmacies for years and reported few suspicious orders to the DEA. These pharmacies include: a New Jersey pharmacy that has pleaded guilty to unlawfully selling controlled substances; another New Jersey pharmacy whose pharmacist-in-charge has been indicted for drug diversion; two pharmacies, one in Florida and one in West Virginia, for which AmerisourceBergen knew the drugs it distributed were likely being sold in parking lots for cash; and, a Colorado pharmacy that AmerisourceBergen knew was its largest purchaser of oxycodone in that state and specifically identified eleven patients as potential “drug addicts” whose prescriptions likely were illegitimate.
“As alleged in the complaint,” U.S. Attorney Sellinger said, “after learning of drug deals in a pharmacy parking lot – the ‘reddest of red flags’ as one AmerisourceBergen employee described – an AmerisourceBergen subsidiary went on shipping thousands of opioids order to that pharmacy and did not report a single one of them to the DEA. Another example: despite telling the DEA that it had ceased selling controlled substances to a New Jersey pharmacy, an AmerisourceBergen subsidiary used a proxy distributor – a straw – to continue funneling hundreds of opioids orders to that same pharmacy. None of those suspicious orders were reported to DEA either. These were not isolated incidents, but are indicative of AmerisourceBergen’s widespread misconduct.”
The complaint further alleges that AmerisourceBergen not only ignored red flags of diversion, but also relied on internal systems to monitor and identify suspicious orders that were deeply inadequate, both in design and implementation. These systems allegedly flagged only a tiny fraction of suspicious orders, thereby enabling diversion and AmerisourceBergen’s failure to report orders it was legally obligated to identify to the DEA. In fact, the complaint asserts that in the midst of the opioid epidemic, AmerisourceBergen intentionally altered its internal systems to reduce the number of controlled substances reported as suspicious. Even for the small percentage of orders that AmerisourceBergen did identify as suspicious, the company routinely failed to report them to the DEA.
The government’s complaint alleges that for years AmerisourceBergen flouted its legal obligations and prioritized profits over the well-being of Americans.
If AmerisourceBergen is found liable, it could face escalating civil penalties depending on when each violation occurred and the type of controlled substance at issue. Specifically: up to $10,000 for each reporting violation before November 2015, up to $16,864 for each violation between November 2015 and October 2018 and for each violation relating to a suspicious order for a non-opioid controlled substance not reported after October 2018 , and up to $109,374 for each violation relating to a suspicious opioid order not reported after October 2018, potentially totaling billions of dollars in penalties. The court also may award injunctive relief to prevent AmerisourceBergen from committing future CSA violations.
The claims made in the complaint are allegations that the United States must prove by a preponderance of the evidence if the case proceeds to trial.
The government is represented by Assistant U.S. Attorneys Hayden M. Brockett and Jordann R. Conaboy for the District of New Jersey, Trial Attorneys Michael Wadden, Amy DeLine, and Deborah Sohn of the Department of Justice Civil Division’s Consumer Protection Branch, Assistant U.S. Attorneys Anthony D. Scicchitano and Landon Jones for the Eastern District of Pennsylvania, Assistant U.S. Attorneys Amanda Rocque and David Moskowitz for the District of Colorado, and Assistant U.S. Attorneys Elliot M. Schachner and Diane Leonardo for the Eastern District of New York. The DEA, under the direction of Special Agent in Charge Gibson in New Jersey, collaborated with the Department to investigate the case.